"Before It Happens To You" and" Resynchronization and Defibrillation for Heart Failure: A Practical Approach" represent Sackner-Bernstein's perspective of scientifically-based and practical application of patient advocacy - focused on both safety and innovation. At the time of the publication of these books, Sackner-Bernstein's position at North Shore University Hospital allowed him to focus on both clinical care and clinical research. He also consulted for the Food and Drug Administration. This followed his 10 years on faculty at Columbia University. Subsequently Sackner-Bernstein served as Chief Medical Officer at Clinilabs, where he led the early phase drug development unit, where he oversaw phase 1 and First-in-Human trials. Dr. Sackner-Bernstein's research contributions include focus on medical product safety. In the mid 1990's, his team reported significant fluid retention in heart failure patients treated with a vasodilating beta-blocker (Coreg™, carvedilol), while also demonstrating that those patients so affected could be managed successfully and realize similar long-term benefit as seen in those patients without the initial fluid retention. In 2001, Sackner-Bernstein reported the aggregated data from all clinical trials to estimate the risk of death associated with implantation of biventricular pacemakers. The data predicted accurately that the ongoing pivotal trial would not be powered to show a long-term survival benefit because it had not accounted adequately for this initial risk. In 2003, Sackner-Bernstein led the team that reported an association between the use of nesiritide (Natrecor™) and subsequent risk of death in patients with acute heart failure. This report served as a catalyst to persuade Sponsors to undertake clinical outcome trials in acute heart failure instead of focusing only on surrogates.Dr. Sackner-Bernstein received his B.S.E. from the Moore School of Electrical Engineering at the University of Pennsylvania and his M.D. from Jefferson Medical College. He completed training in Internal Medicine and Cardiology at Mount Sinai Hospital in New York. In parallel with his expertise in regulatory science and FDA operations, Dr. Sackner-Bernstein brings to his role 20 years of experience in clinical practice, clinical research and healthcare management.